MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE® OASYS®; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Neovascularization (1978); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 a call was received from a representative at an eye care provider¿s (ecp) office who reported the patient (pt) was diagnosed with ¿sterile marginal corneal ulcers¿ od while wearing the acuvue oasys brand contact lenses (cl).On 06jun2018 the pts medical records were received and additional medical information was provided: on (b)(6) 2017: contact lens follow-up (fu); pt wearing a competitor contact lens brand, but wants to try acuvue oasys brand contact lenses; pt given trial lenses and fu appointment for cl check in 1 week.On (b)(6) 2017: cl fu; pt has no complaints, doing well, happy with comfort and fit.On (b)(6) 2017: pt complains of od red and painful; extended-wear (ew) worn for 1 week straight before symptoms: redness, pain, tearing; od conjunctive with injection, od corneal with ulcer ¿ peripheral large x 3; impression: marginal corneal ulcer, right eye; plan: pt prescribed vigamox q 2 h od; no cl wear; pt to return to office in 4 days for fu.On (b)(6) 2017: fu corneal ulcer; good compliance with vigamox q2h od; symptoms: foggy vision, pain, tearing; od cornea: ulcer ¿ peripheral small x 3; impression: marginal corneal ulcer, od; plan: continue vigamox q2h od, return to office in 2 days for fu on (b)(6) 2017: fu corneal ulcer od; good compliance with vigamox q 2h; symptoms: less pain, less photophobia, less redness, blur continues; od cornea: ulcer ¿ peripheral, trace staining; impression: marginal corneal ulcer od; plan: continue vigamox q4h, no cl wear, return in 5 days for fu.On (b)(6) 2017: fu corneal ulcer; besivance q4h od, good compliance; symptoms: blur better, no pain, no irritation, no photophobia; od cornea: scar small peripheral x 2; impression: unspecified corneal scar and opacity; plan: continue besivance q4h od one day, start cl again 1 day, fu prn.No additional medical information has been received.No additional medical information is expected.The suspect lenses were discarded.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00mpn6 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On (b)(6) 2022 the patient (pt) provided additional medical record information to the johnson and johnson legal department.Date of visit: 26aug2019.Contact lens (cl) exam; history of od ulcers.Corrected va: 20/20 -2.Od cornea: clear; stroma: mild scarring peripheral, round scar od; anterior chamber: deep and quiet dx: peripheral opacity of cornea, od result of ulcers in 2017 - was switched from acuvue2 (a2) to oasys cls pt was long time extended wear (ew) pt in a2, did not indicate clearly if she was sleeping in oasys cls or not at the time of ulcers; not vision threatening, bcva 20/20 od; discussed risks of cl wear with pt; monitor yearly date of visit: (b)(6) 2020.Pt needs more contact lenses.Corrected va: 20/25 -2 od.Od cornea: ghost vessel nasal encroaching towards central od; stroma: mild scarring peripheral, round scar od; tear film: debris in tears; anterior chamber: deep and quiet dx: peripheral opacity of cornea, od result of ulcers in 2017 - was switched from a2 to oasys cls pt was long time ew pt in a2, did not indicate clearly if she was sleeping in oasys cls or not at the time of ulcers; not vision threatening, bcva 20/20 od; discussed risks of cl wear with pt; monitor 6 months; reviewed hygiene and wearing schedule and hand washing date of visit: (b)(6) 2021.Pt c/o interested in new glasses.Corrected va: 20/30 od.Od cornea: ghost vessel nasal encroaching towards central od; stroma: mild scarring peripheral, round scar od; tear film: debris in tears; anterior chamber: deep and quiet dx: peripheral opacity of cornea, od result of ulcers in 2017 - was switched from a2 to oasys cls pt was long time ew pt in a2, did not indicate clearly if she was sleeping in oasys cls or not at the time of ulcers; not vision threatening, bcva 20/20 od; discussed risks of cl wear with pt; monitor 6 months; reviewed hygiene and wearing schedule and hand washing severity: mild; change: stable regular astigmatism od - update specs; myopia ou - update specs date of visit: 05nov2021 pt c/o od still a little blurry in ou for years corrected va: 20/30 od od cornea: ghost vessel nasal encroaching towards central od; tear film: stroma: mild scarring peripheral, round scar od; tear film: debris in tears ou; anterior chamber: deep and quiet dx: regular astigmatism od - update cl rx and trying biofinity cls - rtc for cl disp and rtc 6 months for cl check-up and corneas myopia ou - update cl rx and trying biofinity cls - return to clinic (rtc) for cl disp and rtc 6 months for cl check-up and corneas no additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® OASYS®
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7655767
• MDR Text Key: 112946991
• Report Number: 1057985-2018-00086
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: PH
• Device Lot Number: B00MPN6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 34 YR
• Patient Sex: Female